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NCT04383587 Clinical Trial

Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers

COVID-19 Clinical Trial

Official title:
Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04383587
Other study ID # 20-004054
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 6, 2020
Est. completion date July 31, 2020

Study information
Verified date April 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to identify healthcare workers with SARS CoV 2 antibodies who have not been previously diagnosed and are presumed COVID-19 negative, then determine the level of immunity in this population which could inform further decisions about widespread antibody testing in a healthcare worker population.

Description:

Enrolled participants will complete a survey gauging their level of confidence they will be antibody positive. Participants will then complete serologic testing for SARS CoV 2 IgG antibodies. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between a pre-test confidence level using a Likert scale and actual antibody positivity.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date July 31, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years old. - Mayo Clinic employee in procedural and surgical area. - Suspected COVID-19 exposure. - Completed PCR test twice with negative results. Exclusion Criteria: - Refusal to participate in this study.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Serologic testing
COVID19 IgG antibody testing to be performed

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With COVID-19 Antibodies Presence of IgG antibodies detected 1 month
Secondary Ability to Predict Immune Status/Antibody Positivity Survey of participants to gauge their confidence they will be antibody positive Single point in time prior to COVID-19 Antibody testing
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